The effects on beagles of long-term administration of 20% Travamulsion fat emulsion

The tolerance of 20% Travamulsion intravenous fat emulsion (Travenol Laboratories, Inc., Deerfield, IL) was studied using male beagle dogs. Physiologic (0.9%) saline, USP, was used as the control, and 10% Travamulsion Intravenous fat emulsion (Travenol Laboratories) as the reference article. The 20 and 10% emulsions were administered intravenously to each of eight animals for 91 days at 20 and 40 ml/kg/day, respectively. These dosages were administered over 4 hr and they correspond to approximately 4 g of lipid as soybean oil per kilogram of body weight. The saline was administered to eight animals at 40 ml/kg/day. On day 92, one-half of the animals in each group were necropsied. The remaining dogs were observed and necropsied on day 122. Toxicity was assessed on animal survival; changes in body weight, urinalysis, and hematologic, and serum biochemical analyses; ophthalmologic examination; gross pathology; and histopathology. The results obtained for the 20% Travamulsion fat emulsion correlated well with those for the 10% Travamulsion fat emulsion. The emulsions were well tolerated and all animals survived and gained weight. The 20% Travamulsion fat emulsion administered provided about 45% of the total caloric requirement of the dog, which is equal to an often used clinical dose. However, caloric administration in the form of lipid emulsion in relation to total energy required was performed at three to six times the indicated clinical rate. In addition to demonstrating that it is safe for prolonged administration, the 20% Travamulsion fat emulsion offers an advantage over the 10% Travamulsion fat emulsion in providing the same amount of calories because it produces lower serum levels of phospholipid, cholesterol, and triglyceride, and the volume of emulsion required is reduced.